Octave’s MS disease activity test now available across US
Blood test uses biomarkers to assess MS activity
Octave Bioscience’s Multiple Sclerosis Disease Activity (MSDA) test, which uses data from blood biomarkers to assess multiple sclerosis (MS) disease activity, is now available across all 50 U.S. states to help guide clinicians’ decisions about care.
Octave said the test received certification from the New York State Clinical Laboratory Evaluation Program (CLEP).
That certification is a “major milestone,” Doug Biehn, president and CEO of Octave, said in a company press release. “The fact that the MSDA Test has achieved this quality standard should give all U.S. physicians the greatest possible confidence in the rigor and reliability of Octave and its MSDA Test results.”
MS is a chronic disorder that affects the brain and spinal cord. MS symptoms can vary widely from person to person. Managing the disease is often complex, and depends mostly on a clinician’s interpretation of symptoms and MRI scans.
Octave says its MSDA test offers a complementary approach to guide care decisions by providing quantitative data about disease activity. The test measures the levels of 18 proteins in the blood, and uses artificial intelligence to make sense of the data and provide real-time reports with “actionable insights,” Octave said. It’s the first validated test of its kind, according to the company.
Measuring individual patients’ disease activity
“Given the heterogeneity of MS, having the ability to look beyond the clinical exam and incorporate an individual’s measured disease activity will allow us to focus on managing the needs of each patient,” said Bianca Weinstock-Guttman, MD, a neurology professor at the University at Buffalo.
The test has been available since 2022, when it was commercially launched, to patients followed in MS centers of excellence, academic institutions, and independent neurology practices across the U.S.
Clinicians who have been using it as part of routine MS care say the test has been useful in guiding treatment decision-making. A study found that in nearly one out of five cases where the test was used, MSDA results led to changes in care decisions, and more than half of the clinicians agreed or strongly agreed that a single MSDA test result helped guide their decisions.
The MSDA test can be administered to people with MS at any stage of their disease course, including years after disease onset and diagnosis.
After a blood sample is collected, the MSDA test is performed in Octave’s laboratory, which has Clinical Laboratory Improvement Amendments certification and College of American Pathology accreditation.
The CLEP’s certification, which is based on an evaluation protocol to assess the performance of laboratory testing, is another testament to the rigor and reliability of MSDA test results, according to Octave.
“The MSDA Test has the potential to redefine clinical care for MS patients today and well into the future,” said Weinstock-Guttman.
Stephanie Buxhoeveden, chief scientific officer at the Accelerated Cure Project for Multiple Sclerosis, praised the test’s usefulness. “As a clinician, researcher, advocate and MS patient, I live the challenges of managing MS,” Buxhoeveden said. “The MSDA Test has given me invaluable insights that helped me navigate my own disease while also providing tremendous peace of mind.”
The Accelerated Cure Project, a nonprofit organization dedicated to accelerating MS research efforts, contributed data from its biorepository for the development of the MSDA test.
“The Octave MSDA Test is the compass to care that we have been seeking,” Buxhoeveden said.
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